A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture

Sponsor

University of Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT00489749

Collaborator

Royal Alexandra Hospital (Other), Edmonton Orthopaedic Research Society (Other), DonJoy Orthotics (Industry)

110

Enrollment

Location

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to determine the effect of protected early weightbearing (PEWB) compared to non-weightbearing (NWB) after surgery for an Achilles tendon rupture (ATR) on health related quality of life (HRQL) in the initial six week period after surgery, functional recovery over time, return to work and activity and complications. We hypothesized that PEWB following ATR repair would result in: i) improved HRQL in the initial postoperative period, ii), a quicker recovery of HRQL, strength and endurance, iii) earlier return to work and sport, and iv) no increase in complications, such as re-rupture compared to NWB.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendon Rupture	Procedure: Protected early weightbearing/Achilles tendon surgery	N/A

Detailed Description

Achilles tendon rupture (ATR) is commonly treated with open surgical repair. Following surgical repair, there are a variety of protocols, ranging from complete immobilization to immediate postoperative mobilization with early weightbearing. However, no clear consensus regarding the optimal postoperative rehabilitation protocol for ATRs exists. Early rehabilitation after ATR has been shown to be beneficial in animal and human studies. Human prospective studies and randomized controlled trials have shown that early postoperative mobilization do not pose additional risks compared to cast immobilization, with a trend toward a reduction in lost work days and an earlier return to sport. However, these trials define early postoperative mobilization differently (i.e. use different combinations of weightbearing and range of motion). This makes it difficult to determine which factor in the early rehabilitation process plays an important role in optimizing recovery. An important component of early rehabilitation is weightbearing.

Comparison: Patients weightbearing in the early rehabilitation period after surgical repair of the Achilles tendon compared to patients non-weightbearing after the surgical repair of the Achilles tendon repair. With the exception of weightbearing status, both groups performed the same rehabilitation program.

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

The Influence of Protected Early Weightbearing Versus Nonweightbearing After Surgical Repair of the Achilles Tendon

Study Start Date :

Oct 1, 2003

Actual Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

Health related quality of life: Short form 36 questionnaire [six weeks]

Secondary Outcome Measures

Health related quality of life: Short Form-36 questionnaire [3 and 6 months]
Level of activity: tailored question [six weeks, 3 months, and 6 months]
Major complications: chart review [6 weeks, 3 months, and 6 months]
Minor complications: chart review [6 weeks, 3 months, and 6 months]
Isometric muscle strength: hand held myometer [6 weeks, 3 months, and 6 months]
Muscle endurance: heel raise counting device [6 months]
Calf circumference: standardized tape measurement [6 weeks, 3 months, and 6 months]
Return to work/sport: tailored question [6 weeks, 3 months, and 6 months]
Physiotherapy utilization: tailored question [6 weeks, 3 months, and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

closed and complete Achilles tendon rupture
seen within 14 days of injury in hospital

Exclusion Criteria:

unwilling to follow the study's rehabilitation protocol
unable to speak or read English
co-morbid conditions such as diabetes and neurological or collagen disease
pregnancy
recent immunosuppressant or fluoroquinolone therapy
previous Achilles tendon symptoms
previous ipsilateral rupture
sustained an additional injury not allowing weightbearing
an Achilles tendon avulsion injury
unfit for surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2B7

Sponsors and Collaborators

University of Alberta
Royal Alexandra Hospital
Edmonton Orthopaedic Research Society
DonJoy Orthotics

Investigators

Principal Investigator: Nadr Jomha, MD, PhD, University of Alberta Division of Orthopaedic Surgery
Study Director: Amar Suchak, MD, University of Alberta Department of Medicine and Dentistry